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510(k) K211471

Balanced Knee System Uni by Ortho Development Corporation — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2021
Date Received
May 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

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